国家: 以色列
语言: 英文
来源: Ministry of Health
NITISINONE
TRUEMED LTD, ISRAEL
A16AX04
TABLETS
NITISINONE 10 MG
PER OS
Required
CYCLE PHARMACEUTICALS LTD., UK
NITISINONE
Treatment of patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
2020-06-29
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 THE MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY NITYR NITISINONE 2 MG NITYR NITISINONE 5 MG NITYR NITISINONE 10 MG TABLETS COMPOSITION: ACTIVE INGREDIENT: EACH TABLET OF NITYR 2 MG CONTAINS NITISINONE 2 MG EACH TABLET OF NITYR 5 MG CONTAINS NITISINONE 5 MG EACH TABLET OF NITYR 10 MG CONTAINS NITISINONE 10 MG FOR A LIST OF INACTIVE AND ALLERGENIC INGREDIENTS IN THE PREPARATION, see section 6 ”Further Information“. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Nityr tablets is given to treat a hereditary disease called tyrosinemia type 1. In this disease, your body is unable to completely break down the amino acid tyrosine )amino acids are building blocks that build the proteins in our body(, resulting in the body accumulating a substance that is harmful to it. Nityr tablets prevent the breakdown of the amino acid tyrosine in the first place, and as a result, the harmful substance does not accumulate in your body. Because tyrosine remains in the body, a special dietary regimen based on foods with low amounts of tyrosine and phenylalanine should be maintained during treatment with Nityr tablets. THERAPEUTIC GROUP: treatment of essential metabolic system defects. 2. BEFORE USING THE MEDICINE: DO NOT USE THE PREPARATION IF: • You are sensitive )allergic( to the active ingredient nitisinone or to any of the other ingredients contained in the medicine )please see section 6 ”Further Information“(. • You are breastfeeding. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE AND DURING TREATMENT WITH NITYR TABLETS, TELL THE DOCTOR: • If redness 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT NITYR 2mg, 5mg, 10mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg, 5mg, 10mg nitisinone. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. White to beige, round, flat tablet, which may display light yellow to brown speckles, debossed with “L” on one side and the strength (“2”mg, “5”mg,”10”mg) on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION NITYR tablets treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients. Posology Treatment of all genotypes of the disease should be initiated as early as possible to increase overall survival and avoid complications such as liver failure, liver cancer and renal disease. Adjunct to the NITYR tablets treatment, a diet deficient in phenylalanine and tyrosine is required and should be followed by monitoring of plasma amino acids (see sections 4.4 and 4.8) The recommended initial dose in the pediatric and adult population is 1mg/kg body weight administered orally. The dose of NITYR tablets should be adjusted individually. It is recommended to administer the dose once daily. However, due to the limited data in patients with body weight <20 kg, it is recommended to divide the total daily dose into two daily administrations in this patient population. _Dose adjustment_ During regular monitoring, it is appropriate to follow urine succinylacetone, liver function test values and alpha-fetoprotein levels (see section 4.4). If urine succinylacetone is still detectable one month after the start of NITYR tablets treatment, the NITYR tablets dose should be increased to 1.5 mg/kg body weight/day divided in 2 doses. A dose of 2 mg/kg body weight/day may be needed based on the evalua 阅读完整的文件